Transnasal lacrimal insert

ABSTRACT

A temporary transnasal lacrimal insert is used in a surgical procedure for improving drainage from a patient&#39;s lacrimal sac to his or her nasal cavity. The insert includes a tubular member with a proximal end and an enlarged distal end. The insert also includes an attachment element about which ends of a silastic tube can be fastened. In the procedure, a hole is created extending from the lacrimal sac into the nasal cavity using surgical techniques or a laser probe. Then, opposite ends of a silastic tube are introduced through the patient&#39;s upper and lower puncta, through the patient&#39;s upper and lower canaliculi, through the lacrimal sac, through the hole, and into the nasal cavity. The ends of the silastic tube are then threaded through the passage in the insert. The insert is then placed from the nasal cavity into the hole by forcing the proximal end of the insert through the hole and into the lacrimal sac, and abutting the enlarged distal end, which is larger than the hole, against a surface in the nasal cavity surrounding the hole. The ends of the silastic tube are then fastened to the attachment element of the insert. Excess tube extending into the nasal cavity is then cut short to reduce nasal irritation. After the hole has sufficiently healed in about 3-6 months, the silastic tube and the insert are removed.

FIELD OF THE INVENTION

[0001] The present invention relates generally to medical devices andprocedures and, more particularly, to devices and procedures forlacrimal tract surgery for improving tear drainage.

BACKGROUND OF THE INVENTION

[0002] One of the major problems with known dacryocystorhinostomy (DCR)procedures for improving lacrimal tract drainage is closure of theinduced drainage hole between the lacrimal sac and the nasal cavity. Thepossibility of hole closure exists even with the newer improved laserDCR techniques.

[0003] In procedures for improving drainage using nasolacrimal tubes orstents, the tubes are inserted from the conjunctiva or the lacrimal sacinto the nasal cavity. Common problems with these devices includedisinsertion, protrusion and dislocation of and intolerance to thetubes.

[0004] Accordingly, one object of the present invention is to provide aninsert usable in a procedure for providing lacrimal tract drainage thatis stable, temporary, and that preserves the draining function of thenasolacrimal duct after surgery. Another object of the invention is toprovide a device that keeps the rhinostomy hole open during the healingprocess after surgery. A further object of the invention is to providean insert that is easily inserted and is easily accessible and removableafter its task has been accomplished. Another object of the invention isto provide an insert that stabilizes and substantially preventsdislocation of a silastic tube installed in the lacrimal tract.

SUMMARY OF THE INVENTION

[0005] In accordance with the present invention, a transnasal lacrimalinsert is provided for use in a surgical procedure for improvingdrainage from a patient's lacrimal sac to his or her nasal cavity. Theinsert includes a tubular member having a proximal end and an enlargeddistal end. The insert also includes a rod about which ends of asilastic tube can be fastened.

[0006] In the procedure, a hole is created extending from the lacrimalsac into the nasal cavity using surgical techniques or a laser probe.Then, opposite ends of a silastic tube are introduced through thepatient's upper and lower puncta, through the patient's upper and lowercanaliculi, through the lacrimal sac, through the hole, and through thenasal cavity. The ends of the silastic tube are then threaded throughthe passage in the insert. The insert is then inserted through the nasalcavity into the hole by forcing the proximal end of the insert throughthe hole and into the lacrimal sac, and abutting the enlarged distalend, which is larger than the hole, against a surface in the nasalcavity surrounding the hole. The ends of the silastic tube are thenfastened to the rod in the insert. Excess tube extending from the nasalcavity is then cut short. After the hole has sufficiently healed inabout 3-6 months, the silastic tube and the insert are removed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007]FIG. 1 is a front, part-sectioned view of the human lacrimaltract.

[0008]FIG. 2 is a front, part-sectioned view of the lacrimal tractillustrating use of a silastic tube in accordance with a prior art laserDCR procedure.

[0009]FIG. 3 is a perspective view of a transnasal lacrimal insert inaccordance with the invention.

[0010]FIG. 4 is a side section view of the FIG. 3 insert.

[0011]FIG. 5 is a front, part-sectioned view of the lacrimal tractillustrating use of the insert in accordance with the invention.

DETAILED DESCRIPTION

[0012]FIG. 1 illustrates the anatomy of the human lacrimal tract.Secretory or lacrimal glands 10 above the eye 12 produce tears, whichcover the anterior surface of the eye 12. A lacrimal excretory system ortear drainage system is provided for draining tears into the nasalcavity 14. The lacrimal excretory system includes upper and lower puncta(or openings) 16 at the upper and lower eyelids, respectively, and upperand lower canaliculi 18 leading from the corresponding puncta 16 into alacrimal sac 20. A nasolacrimal duct 22 connects the lacrimal sac 20 tothe nasal cavity 14.

[0013] Obstruction or closure of the drainage system at the nasolacrimalduct 22 can cause constant tearing, recurrent infection of the lacrimalsac (Dacryocystitis), and spread of infection to the adjacent tissues(Orbital cellulitis) and to the brain (Brain abscess).

[0014] Common causes of nasolacrimal duct obstruction include congenitalocclusion in children, idiopathy, trauma, chronic infections, tumors,foreign bodies, and heredity.

[0015] There are several known methods of treating nasolacrimalobstruction. For instance, nasolacrimal obstruction in children can betreated by probing the nasolactrimal duct. However, this procedure isonly feasible for use in children.

[0016] In another procedure known as Conjunctivo-dacryocystorhinostomy,the lacrimal excretory system is completely bypassed. In this procedure,a passage from the eye to the nose is opened by surgery and a tube(typically a Jones tube or a Cooper tube) is installed in the passage tocompletely bypass the lacrimal excretory system.

[0017] In DCR procedures, a passage from the lacrimal sac to the nose isopened by surgery with or without installing a tube.

[0018] A number of problems are associated with these known procedures.First, they are generally major surgical procedures that are difficultand time consuming. Also, most of the procedures require generalanesthesia. In addition, most of the procedures require facial incisionand are typically very bloody. Patients are also likely to feelsubstantial pain and discomfort in the post-operative period.

[0019] The tubes used in procedures involving tube installation arepermanent and large. They can become clogged after installation by mucusor secretions. In addition, in many cases, bacterial colonization at thetubes will produce odor. Also, dislocation and protrusion of tubes isnot uncommon.

[0020] The newer laser DCR procedure is a significant improvement overthe other known procedures. In the laser DCR procedure, a passage fromthe lacrimal sac to the nose is opened by a laser probe followed bysilastic intubation as shown in FIG. 2.

[0021] Unlike the other procedures, laser DCR is a minor surgicalprocedure and is performed under local anesthesia. It is also relativelyeasy to perform, and it takes only about 10-15 minutes. No facialincision is involved, and there is substantially no blood loss. Also,there is minimal post-operative pain. Furthermore, no permanent tubesare used in the procedure.

[0022] In the laser DCR procedure, the lacrimal sac 20 is first inflatedwith Healon, a clear viscous liquid. A fiber optic laser probe (notshown) is then passed into the puncta 16, through a canaliculus 18 andinto the sac 20. The tip of an endoscope (not shown) is placed in thenasal cavity 14 to confirm proper positioning of the probe. Laser energyis then applied by the probe to form a rhinostomy hole 24 having adiameter of about 5-7 mm extending from the lacrimal sac 20 into thenasal cavity 14. Thereafter, the laser probe and endoscope are removed.Next, a silastic tube 26 is installed. Metal tips (not shown) atopposite ends of the silastic tube 26 are passed from upper and lowerpuncta 16 into their respective canaliculi 18, into the sac 20 and thenthrough the laser induced hole 24 into the nasal cavity 14. The ends ofthe silastic tube 26 are then tied in a knot inside the nasal cavity,and excess tube including the metal tips are cut short as shown in FIG.2. The silastic tube 26 is removed after 3-6 months with the expectationthat the laser induced hole 24 will remain open during the healingprocess.

[0023] There are, however, a number of problems associated with thisprocedure. First, the laser induced hole 24 tends to close due to itssmall diameter. Also, the silastic knot can be easily displaced fromnasal cavity 14 into the lacrimal sac 20 by, for example, nose blowingand sneezing. Dislocation of the silastic tube 26 often results in aspontaneous closing of the hole 24. In addition, the silastic knot maycause nasal irritation due to its significant extension into the nasalcavity 14.

[0024] In accordance with the present invention, a transnasal lacrimalinsert 100 is provided for use in a procedure for providing lacrimaltract drainage. As shown in FIGS. 3 and 4, the insert 100 comprises agenerally L-shaped tubular member 102 with a circular base 104 flangedat one end 106 (which will be referred to as the enlarged distal ornasal end 106) of the tubular member 102. The base 104 includes anopening 108 leading to the passage 110 extending through the tubularmember 102. A rod 112 extends across the opening 108 dividing theopening 108 into two semi-circular openings 108A and 108B. The rod formsan attachment element about which ends of a silastic tube can befastened as will be described in further detail below. The opposite end114 of the tubular member 102, which will be referred to as the lacrimalor proximal end, is tapered forming a generally sharp edge to facilitatepenetration of the insert 100 into a rhinostomy hole as will be furtherdescribed below.

[0025] The insert 100 comprises a biocompatible material suitable foruse in contact with tissue. It is preferably a soft, flexible materialsuch as, for example, silicone and silastic materials.

[0026] The tubular member 102 has a wall thickness of about 0.5 mm to 1mm. The base 104 has a thickness of about 0.5 mm to 1 mm and an outerdiameter of about 10 mm.

[0027] A variety of inserts having different tubular member lengths(indicated by the dimension “L” in FIG. 4) can be provided depending onthe patient on which it is to be used. For example, inserts havingtubular member lengths of 8 mm, 10 mm, 12 mm and 14 mm can be provided.

[0028] The initial steps of the procedure using the insert 100 inaccordance with the invention are similar to those of the laser DCRprocedure previously discussed. The lacrimal sac is first inflated withHealon. A fiber optic laser probe (not shown) is then passed into apuncta 16, through a canaliculus 18 and into the lacrimal sac 20. Thetip of an endoscope (not shown) is placed in the nasal cavity 14 toconfirm proper positioning of the probe. Laser energy is then applied bythe probe to open a hole 116 from the lacrimal sac 20 into the nasalcavity 14. The probe is moved about and back and forth during this stepto enlarge the hole to a diameter of about 5-7 mm. Thereafter, the laserprobe and endoscope are removed.

[0029] Next, a silastic tube 120 is installed. Metal tips at oppositeends of the silastic tube are passed from upper and lower puncta 16,through the respective upper and lower canaliculi 18 into the sac 20,then through the laser induced hole 116, and through the nasal cavity 14to outside the patient's nose.

[0030] The metal ends of the silastic tube 120 are then threaded throughthe passage 110 in the insert 100. The silastic tube ends are eachintroduced through the proximal end 114 of the insert 100 and out of adifferent one of the openings 108A and 108B in the base 104. The insert100 is then introduced from the nasal cavity 14 into the laser inducedhole 116 by forcing the tapered proximal end 114 of the insert 100through the hole 116 and into the lacrimal sac 20. The base 104 willabut the surface of the nasal cavity 14 surrounding the hole 116 sincethe base 104 will have a larger diameter than the hole 116. The insert100 will accordingly be kept from being displaced into the lacrimal sac20. The ends of the silastic tube 120 are then tied about the rod 112 atthe base 104. Excess tube extending into the nasal cavity including themetal tips is then cut short as shown in FIG. 5.

[0031] The silastic tube 120 keeps the insert 100 from falling out ofthe hole 116 into the nasal cavity 14. At the same time, the insert 100keeps the silastic tube from being displaced into the lacrimal sac.

[0032] The silastic tube 120 and the insert 100 are removed after about3-6 months after the hole 116 has healed sufficiently.

[0033] This procedure has a number of significant advantages over theconventional laser DCR and other procedures previously described. First,the insert 100 substantially prevents hole closure by mechanicalresistance. Migration of epithelium occurs around the insert 100 toreduce the likelihood of closure.

[0034] The insert 100 is also temporary, and it therefore does not havethe problems associated with permanent tubes.

[0035] The presence of the insert 100 enables a significantly shortersilastic tube extension into the nasal cavity, thereby reducing nasalirritation.

[0036] By tying the knot of the silastic tube to the rod of the insert100, the knot is kept from dislocating into the lacrimal sac.

[0037] In addition, protrusion and loop formation of the silastic tubeis prevented at the medial canthus.

[0038] Also, the insert 100 permits drainage to be preserved immediatelyafter surgery.

[0039] Furthermore, the insert 100 is easily inserted from the nasalcavity, and it is easily accessible and removable after its task hasbeen completed.

[0040] Thus, the insert 100 and procedure for improving drainage inaccordance with the invention offer significant advantages overconventional devices and procedures.

[0041] While the present invention is described with reference tospecific embodiments, it will be apparent to persons skilled in the artthat many modifications and variations are possible. Accordingly, thepresent invention embraces all alternatives, modifications andvariations that fall within the spirit and scope of the appended claimsand all equivalents thereof.

1. A transnasal lacrimal insert, comprising: a tubular member having apassage extending therethrough, said tubular member having a proximalend and an enlarged distal end; and an attachment element at said distalend of said tubular member about which ends of a silastic tube can befastened, wherein said tubular member and said attachment elementcomprise biocompatible material.
 2. The transnasal lacrimal insert ofclaim 1, wherein said tubular member is generally L-shaped.
 3. Thetransnasal lacrimal insert of claim 1, wherein said insert comprises asoft, flexible material.
 4. The transnasal lacrimal insert of claim 1,wherein said insert comprises silicone.
 5. The transnasal lacrimalinsert of claim 1, wherein said insert comprises silastic material. 6.The transnasal lacrimal insert of claim 1, wherein said tubular memberhas a wall thickness of about 0.5 mm to 1 mm.
 7. The transnasal lacrimalinsert of claim 1, wherein said enlarged distal end comprises a flangeprojecting about said tubular member.
 8. The transnasal lacrimal insertof claim 7, wherein said flange has a circular periphery.
 9. Thetransnasal lacrimal insert of claim 8, wherein said flange has an outerdiameter of about 10 mm.
 10. The transnasal lacrimal insert of claim 7,wherein said flange has a thickness of about 0.5 mm to 1 mm.
 11. Thetransnasal lacrimal insert of claim 1, wherein said proximal end of saidtubular member is tapered to facilitate insertion of the insert in arhinostomy hole, and said proximal end is adapted to stay inside thelacrimal sac.
 12. The transnasal lacrimal insert of claim 1, whereinsaid attachment element comprises an elongated rod extending across anopening at said distal end of said tubular member leading to saidpassage.
 13. A surgical procedure for improving drainage from apatient's lacrimal sac to his or her nasal cavity, comprising the stepsof: (a) inflating the lacrimal sac with Healon; (b) passing a fiberoptic laser probe through the patient's canaliculus and into thelacrimal sac; (c) placing the tip of an endoscope in the nasal cavity tofacilitate proper positioning of the laser probe; (d) applying laserenergy through the laser probe to form a hole extending from thelacrimal sac into the nasal cavity; (e) removing the laser probe andendoscope from the patient; (f) introducing opposite ends of a silastictube, each through one of the patient's upper and lower puncta, throughthe corresponding upper and lower canaliculi, through the lacrimal sac,through the hole, and into the nasal cavity; (g) providing a transnasallacrimal insert, said insert comprising a tubular member having apassage extending therethrough, said tubular member including a proximalend and an enlarged distal end, said distal end being larger than saidhole; and said insert including an attachment element about which endsof a silastic tube can be fastened; (h) threading the ends of thesilastic tube through the passage in the insert from the proximal endthrough the distal end; (i) introducing the insert from the nasal cavityinto the hole by forcing the proximal end of the insert through the holeand into the lacrimal sac, and abutting the enlarged distal end againsta surface in the nasal cavity surrounding the hole; (j) attaching theends of the silastic tube to the attachment element of the insert; (k)cutting and removing excess portions of the silastic tube extending intothe nasal cavity; and (1) removing the silastic tube and the insert fromthe patient after sufficient healing of said hole.
 14. A method ofimproving drainage from a patient's lacrimal sac to his or her nasalcavity, comprising the steps of: (a) creating a hole extending from thelacrimal sac into the nasal cavity; (b) introducing opposite ends of asilastic tube through the patient's upper and lower puncta, through thepatient's upper and lower canaliculi, through the lacrimal sac, throughthe hole, and into the nasal cavity; (c) providing a transnasal lacrimalinsert, said insert comprising a tubular member having a passageextending therethrough, said tubular member including a proximal end andan enlarged distal end, said distal end being larger than said hole; andsaid insert including an attachment element about which ends of asilastic tube can be fastened; (d) threading the ends of the silastictube through the passage in the insert; (e) introducing the insert fromthe nasal cavity into the hole by forcing the proximal end of the insertthrough the hole and into the lacrimal sac, and abutting the enlargeddistal end against a surface in the nasal cavity surrounding the hole;(f) attaching the ends of the silastic tube to the attachment element ofthe insert; and (g) removing the silastic tube and the insert from thepatient after sufficient healing of said hole.
 15. The method of claim14, wherein step (a) comprises applying laser energy from a fiber opticlaser probe inserted in the lacrimal sac.
 16. The method of claim 15,further comprising placing the tip of an endoscope in the nasal cavityto confirm proper positioning of the laser probe.
 17. The method ofclaim 14, wherein step (a) is performed using surgical techniques. 18.The method of claim 14, further comprising cutting and removing excessportions of the silastic tube extending into the nasal cavity after step(f).
 19. The method of claim 14, wherein step (a) comprises creating ahole having a diameter of approximately 5-7 mm.
 20. The method of claim14, wherein step (g) is performed about 3-6 months after step (f). 21.The method of claim 14, wherein said tubular member of said insert isgenerally L-shaped.
 22. The method of claim 14, wherein said insertcomprises a soft, flexible material.
 23. The method of claim 14, whereinsaid insert comprises silicone.
 24. The method of claim 14, wherein saidinsert comprises silastic material.
 25. The method of claim 14, whereinsaid tubular member of said insert has a wall thickness of about 0.5 mmto 1 mm.
 26. The method of claim 14, wherein said enlarged distal end ofsaid insert comprises a flange projecting about said tubular member. 27.The method of claim 26, wherein said flange has a circular periphery.28. The method of claim 27, wherein said flange has an outer diameter ofabout 10 mm.
 29. The method of claim 26, wherein said flange has athickness of about 0.5 mm to 1 mm.
 30. The method of claim 14, whereinsaid proximal end of said tubular member is tapered to facilitateinsertion of the insert in a hole.
 31. The method of claim 14, whereinsaid attachment element comprises an elongated rod extending across anopening at said distal end of said tubular member leading to saidpassage.